Verve Therapeutics(VERV)

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SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Verve Therapeutics, Inc. (NASDAQ: VERV)
Prnewswire· 2024-08-08 15:38
NEW YORK, Aug. 8, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Verve Therapeutics, Inc. (NASDAQ: VERV) on behalf of the company's shareholders. The investigation seeks to determine whether Verve Therapeutics's directors breached their fiduciary duties in connection with recent corporate actions. If you are a shareholder of Verve Therapeutics, Inc. and are interested in obtaining additional information regarding your rights and options, free of charge, please visit us at: h ...
Verve Therapeutics (VERV) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2024-08-08 13:40
Verve Therapeutics (VERV) came out with a quarterly loss of $0.59 per share versus the Zacks Consensus Estimate of a loss of $0.68. This compares to loss of $0.87 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 13.24%. A quarter ago, it was expected that this biotechnology firm would post a loss of $0.68 per share when it actually produced a loss of $0.59, delivering a surprise of 13.24%. Over the last four quarters, the comp ...
VERV The Schall Law Firm Announces it is Investigating Claims Against Verve Therapeutics, Inc.
Prnewswire· 2024-07-09 14:45
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Verve is the subject of an article published by Bloomberg on April 2, 2024. According to the article, the Company "cited safety concerns for pausing enrollment in a study of its gene-editing treatment for people with high cholesterol, delivering a setback to the promising new field of medicine." Based on this news, shares of Verve fell by more than 40% in m ...
Verve Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-07-01 20:05
The employee received a stock option to purchase 76,900 shares of the company's common stock and 19,200 restricted stock units (RSUs). The option has an exercise price of $4.88 per share, which is equal to the closing price of the company's common stock on the date of grant. Such option has a 10-year term and will vest over a period of four years, with 25% of the shares vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments over the following three year ...
Verve Therapeutics Announces Appointment of Nia Tatsis, Ph.D., and Jodie Morrison to its Board of Directors
Newsfilter· 2024-06-28 11:00
BOSTON, June 28, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the appointment of Nia Tatsis, Ph.D., and Jodie Morrison to its board of directors. Dr. Tatsis currently serves as executive vice president, chief regulatory and quality officer, of Vertex Pharmaceuticals. Ms. Morrison currently serves as chief executive officer and director of Q32 Bio I ...
Verve Therapeutics Announces Appointment of Nia Tatsis, Ph.D., and Jodie Morrison to its Board of Directors
GlobeNewswire News Room· 2024-06-28 11:00
"We are thrilled to have Nia and Jodie join Verve's board of directors, lending their decades of impressive experience leading and advising pharmaceutical and biotech companies through critical stages in drug development, manufacturing, and commercialization," said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve Therapeutics. "We look forward to their valuable insights as we focus on pipeline execution with the continued advancement of the Heart-2 clinical trial of VERVE-102 targetin ...
Verve Therapeutics(VERV) - 2024 Q1 - Quarterly Report
2024-05-08 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40489 VERVE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 82-48001 ...
Verve Therapeutics(VERV) - 2024 Q1 - Quarterly Results
2024-05-08 11:15
Exhibit 99.1 Verve Therapeutics Announces Pipeline Progress and Reports First Quarter 2024 Financial Results First patient dosed in Heart-2 Phase 1b clinical trial of VERVE-102 VERVE-201 clinical trial initiation on track for the second half of 2024 Received first milestone payment from Eli Lilly for collaboration on an in vivo gene editing program targeting lipoprotein(a) (Lp(a)) Cash, cash equivalents and marketable securities of $606.4 million; cash runway into late 2026 BOSTON — May 8, 2024 — Verve Ther ...
Verve Therapeutics(VERV) - 2023 Q4 - Annual Report
2024-02-27 13:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40489 VERVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-4800132 (State or other jurisdictio ...
Verve Therapeutics(VERV) - 2023 Q4 - Annual Results
2024-02-27 12:45
[Verve Therapeutics Q4 and Full Year 2023 Earnings Release](index=1&type=section&id=Verve%20Therapeutics%20Q4%20and%20Full%20Year%202023%20Earnings%20Release) [Executive Summary](index=1&type=section&id=Executive%20Summary) Verve Therapeutics reported significant 2023 progress, highlighted by the first human proof-of-concept for in vivo base editing from the VERVE-101 Heart-1 trial, anticipating three clinical-stage programs in 2024, supported by $624 million in cash and an Eli Lilly collaboration - Announced the **first human proof-of-concept data** for in vivo base editing from the Heart-1 Phase 1b clinical trial of VERVE-101[1](index=1&type=chunk)[2](index=2&type=chunk)[5](index=5&type=chunk) - Expects to have **three clinical-stage programs** in 2024 targeting cardiovascular diseases by editing PCSK9 and ANGPTL3 genes[1](index=1&type=chunk)[2](index=2&type=chunk) - Ended the year with a strong cash position of **$624 million**, providing a cash runway into **late 2026**[1](index=1&type=chunk)[16](index=16&type=chunk) - Strengthened collaboration with **Eli Lilly**, an expert in cardiometabolic disease and late-stage development[2](index=2&type=chunk)[15](index=15&type=chunk) [Pipeline Progress and Clinical Updates](index=1&type=section&id=Pipeline%20Progress%20and%20Clinical%20Updates) Verve advanced its gene editing pipeline with VERVE-101 showing LDL-C reduction and FDA IND clearance, and plans to initiate Phase 1b trials for VERVE-102 and VERVE-201 in 2024 [VERVE-101 (Heart-1 Trial & FDA Clearance)](index=1&type=section&id=VERVE-101%20(Heart-1%20Trial%20%26%20FDA%20Clearance)) Interim data from the Heart-1 Phase 1b trial for VERVE-101 demonstrated successful in vivo base editing in humans, leading to significant LDL-C and PCSK9 reductions, with FDA IND clearance enabling U.S. trial expansion and expected enrollment completion in 2024 - VERVE-101 is an in vivo base editing medicine designed to **inactivate the PCSK9 gene** to treat HeFH by **durably reducing low-density lipoprotein cholesterol (LDL-C)**[3](index=3&type=chunk) VERVE-101 Heart-1 Interim Trial Results | Metric | Reduction | | :--- | :--- | | Time-averaged LDL-C | **Up to 55%** | | Blood PCSK9 protein | **Up to 84%** | - The company received **Investigational New Drug (IND) application clearance** from the U.S. FDA in October 2023, enabling the activation of U.S. trial sites[8](index=8&type=chunk) - Verve expects to **complete enrollment** of the Heart-1 clinical trial in 2024 and provide a data update in the **second half of the year**[7](index=7&type=chunk) [VERVE-102 (Heart-2 Trial)](index=3&type=section&id=VERVE-102%20(Heart-2%20Trial)) VERVE-102, targeting PCSK9 with proprietary GalNAc-LNP delivery, plans to initiate its Heart-2 Phase 1b clinical trial outside the U.S. in the first half of 2024 for patients with HeFH or premature coronary artery disease - VERVE-102 targets the same PCSK9 gene as VERVE-101 but uses a proprietary **GalNAc-LNP delivery technology**[9](index=9&type=chunk) - The Heart-2 Phase 1b clinical trial is expected to be initiated in the **first half of 2024**, subject to regulatory clearances outside the U.S[10](index=10&type=chunk) - Following evaluation of data from both Heart-1 and Heart-2 trials, Verve plans to start a randomized, placebo-controlled **Phase 2 trial** of either VERVE-101 or VERVE-102 in **2025**[10](index=10&type=chunk) [VERVE-201](index=3&type=section&id=VERVE-201) VERVE-201 is an in vivo base editing medicine designed to inactivate the ANGPTL3 gene to treat HoFH and refractory hypercholesterolemia, with a Phase 1b clinical trial expected to be initiated in the second half of 2024 - VERVE-201 is designed to **inactivate the ANGPTL3 gene** to treat patients with homozygous familial hypercholesterolemia (HoFH) and refractory hypercholesterolemia[11](index=11&type=chunk) - A Phase 1b clinical trial for VERVE-201 is expected to be initiated in the **second half of 2024**, with an initial regulatory strategy outside the U.S[12](index=12&type=chunk) [Corporate Developments](index=3&type=section&id=Corporate%20Developments) Verve significantly strengthened its financial position in late 2023 by raising approximately $157.7 million in net proceeds through a public offering and a concurrent private placement with Eli Lilly, while also expanding its collaboration with Lilly Recent Financing Activities (December 2023) | Financing Type | Shares Issued | Price Per Share | Net Proceeds | | :--- | :--- | :--- | :--- | | Public Offering | 14,375,000 | $10.00 | **~$134.7M** | | Private Placement (Eli Lilly) | 2,296,317 | $10.00 | **~$23.0M** | - Expanded its collaboration with **Eli Lilly**, which acquired certain rights to Verve's in vivo gene editing programs targeting PCSK9, ANGPTL3, and a third cardiovascular target[15](index=15&type=chunk) - Verve **retains control** of the development and commercialization of all collaboration products under the agreement with Lilly[15](index=15&type=chunk) [Fourth Quarter and Full Year 2023 Financial Results](index=5&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results) Verve ended 2023 with a robust cash position of $624.0 million, with full-year collaboration revenue growing to $11.8 million, increased operating expenses, and a net loss of $200.1 million - Cash, cash equivalents, and marketable securities were **$624.0 million** as of December 31, 2023, expected to fund operations into **late 2026**[16](index=16&type=chunk) Full Year 2023 vs. 2022 Financial Performance (in millions) | Metric | FY 2023 | FY 2022 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | **$11.8** | **$1.9** | **+$9.9** | | R&D Expenses | **$184.9** | **$130.1** | **+$54.8** | | G&A Expenses | **$49.9** | **$37.5** | **+$12.4** | | Net Loss | **($200.1)** | **($157.4)** | **+($42.7)** | Q4 2023 vs. Q4 2022 Financial Performance (in millions) | Metric | Q4 2023 | Q4 2022 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | **$5.1** | **$1.0** | **+$4.1** | | R&D Expenses | **$46.8** | **$37.3** | **+$9.5** | | G&A Expenses | **$12.3** | **$11.4** | **+$0.9** | | Net Loss | **($48.4)** | **($41.1)** | **+($7.3)** | [Selected Condensed Consolidated Financial Information](index=8&type=section&id=Selected%20Condensed%20Consolidated%20Financial%20Information) Condensed consolidated financial statements detail increased collaboration revenue and operating expenses for Q4 and full year 2023, resulting in a larger net loss, while the balance sheet reflects a stronger year-end 2023 financial position with higher cash and total assets Condensed Consolidated Statements of Operations (in thousands) | | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | Collaboration revenue | $11,758 | $1,941 | | Total operating expenses | $234,882 | $167,628 | | Loss from operations | ($223,124) | ($165,687) | | Net loss | ($200,068) | ($157,387) | | Net loss per share | ($3.12) | ($2.91) | Condensed Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $623,950 | $554,808 | | Total assets | $752,688 | $679,223 | | Total liabilities | $153,186 | $128,291 | | Total stockholders' equity | $599,502 | $550,932 |